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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93580

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 09, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

Z-0777-2024
Recall number
Z-0777-2024
Initiated
June 09, 2023
Classification
Class II
Status
Ongoing
Quantity
4,923,471

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of Ultrasound gel can not be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of Ultrasound gel can not be guaranteed.

Code information

Lot Nos. SJ10091019 SJ22111019 SJ01041120 SJ25081020 SJ25061020 SJ20111020 SJ11021021 SJ24061021 SJ03061021 SJ14071021 SJ20091021 SJ09091021 SJ06022023 SJ10091019

Distribution pattern

US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong

Field note

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